BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1946285 · Received January 4, 2011

    Report

    Report Number
    3003742446-2011-00012
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00012 AND 3003742446-2011-00013. A (B)(6) MALE FROM THE (B)(4) STUDY EXPERIENCED RESTENOSIS APPROXIMATELY SEVEN MONTHS POST IMPLANTATION OF TWO CYPHER STENTS. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED HIS RISK FOR MACE INCLUDES HYPERTENSION, HYPERLIPIDEMIA, DIABETES MELLITUS (TYPE II), HISTORY OF ARTHRITIS, APPENDECTOMY, PERMANENT PACEMAKER AND PAST SMOKER. DURING THE INDEX PROCEDURE, THE PATIENT HAD A TARGET LESION TREATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND A NON-TARGET LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE TARGET LESION HAD 80% STENOSIS, WAS TYPE C, DE NOVO AND 30MM IN LENGTH. THE VESSEL WAS 3MM IN DIAMETER. PRE-DILATION WAS CONDUCTED BEFORE A 3.0 X 33MM CYPHER STENT WAS IMPLANTED, AT 18ATM, FOLLOWED BY A 3.0 X 23MM CYPHER STENT, IMPLANTED DISTALLY AT 16ATM. THE STENTS WERE OVERLAPPING. THE RESIDUAL DIAMETER STENOSIS MEASURED 10%. TIMI III FLOW WAS MAINTAINED. THE NON- TARGET LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WAS DE NOVO AND 15MM IN LENGTH. THE VESSEL WAS 2.75MM IN DIAMETER. A 2.75 X 18MM XIENCE STENT WAS IMPLANTED, AT 12ATM. APPROXIMATELY SEVEN MONTHS POST INDEX PROCEDURE THE PATIENT DEVELOPED UNSTABLE ANGINA. A CARDIAC CATHETERIZATION SHOWED SEVERE IN-STENT RESTENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE RESTENOSIS WAS TREATED WITH A DRUG ELUTING STENT AND THE EVENT RESOLVED. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS (SPECIFICALLY DIABETES) AND VESSEL/LESION FACTORS (LONG LESION, TYPE C, 10% RESIDUAL STENOSIS) THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S RESTENOTIC EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED DURING THE INDEX PROCEDURE: A 3.0 X 20MM BALLOON CATHETER AND A 3.0 X 30MM BALLOON CATHETER. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00012 AND 3003742446-2011-00013. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    APPROXIMATELY SEVEN MONTHS POST INDEX PROCEDURE, THE PATIENT DEVELOPED UNSTABLE ANGINA. THE PATIENT'S CORONARY ARTERY DISEASE WAS WORSENING AND A CARDIAC CATHETERIZATION SHOWED SEVERE IN-STENT RESTENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE RESTENOSIS WAS TREATED WITH A DRUG ELUTING STENT. THE PATIENT WAS ENROLLED IN (B)(4) STUDY WITH STALE ANGINA PECTORIS AND A POSITIVE FUNCTION TEST FOR ISCHEMIA. THE PATIENT HAD A TARGET LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND A NON-TARGET LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE TARGET LESION HAD 80% STENOSIS, WAS TYPE C, DE NOVO AND 30MM IN LENGTH. THE VESSEL WAS 3MM IN DIAMETER. THE LESION WAS PRE-DILATED AND A 3.0 X 33MM CYPHER STENT WAS IMPLANTED, AT 18ATM, FOLLOWED BY A 3.0 X 23MM CYPHER STENT, IMPLANTED AT 16ATM. THE STENTS WERE OVERLAPPING. THE NON TARGET LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WAS DE NOVO AND 15MM IN LENGTH. THE VESSEL WAS 2.75MM IN DIAMETER. A 2.75 X 18MM XIENCE STENT WAS IMPLANTED, AT 12ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15111599

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R